U.S. Active Pharmaceutical Ingredient CDMO Market (2025 - 2033) Size, Share & Trends Analysis Report By Product (Traditional API, HP-API, Biologics), By Synthesis (Synthetic, Biotech), By Drug (Innovative, Generics), By Application (Oncology, Glaucoma), By Workflow, And Segment Forecasts

Market Size & Trends

The U.S. active pharmaceutical ingredient CDMO market size was estimated at USD 36.39 billion in 2024 and is projected to reach USD 72.65 billion by 2033, growing at a CAGR of 8.09% from 2025 to 2033. The market is propelled by the presence of several biopharmaceutical companies globally, the growing demand for advanced and high-potency active pharmaceutical ingredient (APIs), and the trend of outsourcing to lower costs and speed time to market. Moreover, the increasing demand for generics, fueled by the patent expiry of blockbuster drugs, is also creating significant opportunities for the CDMOs.

In addition, the growing biologics and biosimilars pipeline that requires capabilities in large-scale fermentation and cell culture is also driving the market growth. A shift toward personalization of medicine has driven pharmaceutical companies to increasingly seek out CDMOs capable of delivering flexibly scheduled, highest quality manufacturing solutions for niche patient populations. Moreover, the increasing incidence of chronic diseases such as cancer and cardiovascular conditions is driving demand for space in new drug delivery systems, further increasing dependence on CDMOs that can not only provide technical feasibility but also regulatory expertise

Furthermore, pharmaceutical companies increasingly prioritize optimized supply chains and strict FDA compliance, making domestic CDMOs a key partner in the U.S. market. Outsourcing production allows businesses to control expenses, safeguard intellectual property, and get through the regulatory approval process more quickly than if they use offshore providers. Furthermore, increased investment from the U.S. in green chemistry, sustainable manufacturing, and eco-friendly practices drives global pharma players' demand for U.S.-based CDMOs.

Opportunity Analysis

Increasing adoption of targeted therapies, monoclonal antibodies, and advanced biologics drugs is fueling the demand for CDMOs, with large-scale biomanufacturing capabilities and biologics expertise. To meet the growing demand for these specialized therapies, CDMOs are increasingly investing in advanced facilities, equipped with advanced cell culture platforms, enabling them to offer high-quality and scalable solutions for biotechnology and pharmaceutical companies. In addition, increasing demand for high-potency APIs (HPAPIs) in the field of immunology, oncology, and rare disease treatments further boosts the demand for APIs, further contributing to market growth.

Technological Advancements

Technological advancements are enhancing quality, scalability, and efficiency across development and manufacturing stages. Furthermore, flow chemistry and continuous manufacturing are increasingly being adopted to reduce costs, enable faster production cycles, and improve reproducibility. Moreover, advanced bioprocessing platforms such as single-use bioreactors, perfusion systems, and high-density cell culture technologies are accelerating large-scale biologics and complex APIs manufacturing. Thus, constant advancement in this field is creating significant competitive advantages for CDMOs, enabling them to offer higher quality and more flexible services to meet the growing demand of pharmaceutical companies.

Product Insights

On the basis of product segment, the market is classified into Traditional Active Pharmaceutical Ingredient (Traditional API), Highly Potent Active Pharmaceutical Ingredient (HP-API), and biologics. The Traditional Active Pharmaceutical Ingredient (Traditional API) segment accounted for the largest revenue share in the API CDMO industry of 44.67% in 2024. The segment's growth is due to the increasing dependence on small-molecule drugs for treating various chronic and acute conditions, further driving the need for APIs. Thus, increasing demand for APIs in the country has positioned U.S.-based CDMOs as key stakeholders in the pharmaceutical value chain, as they offer advanced manufacturing capabilities, strong process expertise, and adherence to stringent regulatory standards.

Biologics segment is anticipated to grow at the fastest CAGR during the forecast period. The segment growth is driven by the rising adoption of advanced therapies such as monoclonal antibodies, vaccines, and cell and gene therapies, which require specialized development and manufacturing capabilities. Moreover, increasing investment by pharmaceutical companies in biologics research and expanding biomanufacturing facilities by U.S.-based CDMOs is further projected to drive the segment's market growth in the coming years.

Synthesis Insights

On the basis of synthesis segment, the market is segregated into synthetic and biotech. The synthetic segment held the largest market share in 2024. The segment's growth is due to the significant use of chemical synthesis processes, enabling cost-efficient and large-scale APIs production. Moreover, increasing demand for small-molecule drugs combined with the availability of advanced manufacturing infrastructure and regulatory familiarity with synthetic pathways in the U.S. is also one of the factors contributing to the segment's market growth.

Biotech segment is anticipated to grow at the fastest CAGR during the forecast period. The segment growth is due to increasing demand for biologics and biosimilars, which require specialized bioprocessing platforms such as single-use bioreactors, perfusion systems, and high-density cell cultures. In addition, increasing investment by pharmaceutical companies in innovative therapies, along with the expanding biomanufacturing capabilities of U.S.-based CDMOs, is further accelerating this trend.

Drug Insights

The market is segregated into innovative and generic drugs. The innovative segment accounted for the largest market share in 2024. The growth of the segment is due to the strong presence of pharmaceutical companies in the country, which are continuously investing in the development of novel molecules and advanced therapies. Moreover, higher pricing potential and faster adoption of innovative treatments for complex and rare diseases further strengthen the demand for CDMO services, as companies increasingly rely on outsourcing partners for specialized expertise and large-scale manufacturing.

The generics segment is anticipated to grow at the fastest CAGR during the forecast period. This growth is due to the increasing number of patent expirations of blockbuster drugs, rising demand for affordable medicines across the U.S., and favorable government initiatives to expand patient access to cost-effective therapies. Pharmaceutical companies are increasingly outsourcing these activities to CDMOs to optimize the production costs and to meet the growing demand for generic APIs

Application Insights

On the basis of indication segment, the market is segregated into oncology, hormonal, glaucoma, cardiovascular disease, diabetes, and others. The oncology segment held the largest market share in 2024 due to the rising prevalence of cancer in the U.S. and the growing adoption of targeted therapies, immunotherapies, and monoclonal antibodies, creating substantial demand for specialized API development and manufacturing. Thus, the expanding oncology drug pipeline, along with continuous investment in advanced biologics and novel small molecules, is contributing to the segment market growth.

Glaucoma segment is anticipated to grow at the considerable CAGR during the forecast period. The segment growth is due to increasing geriatric population in the U.S. The increasing number of older population is leading to a higher prevalence of age-related eye disorders, further driving the demand for effective glaucoma therapies. This trend, combined with rising awareness and improvements in ophthalmic drug delivery, is expected to strengthen the role of CDMOs in supporting glaucoma-related API development and manufacturing.

Workflow Insights

On the basis of workflow segment, the market is segregated into clinical and commercial. The commercial segment dominated the market in 2024 owing to the large-scale production requirements of approved drugs, which necessitate consistent supply and advanced manufacturing capabilities. The presence of established CDMOs in the U.S. with strong infrastructure, regulatory compliance, and capacity to handle high-volume production is further contributing to the dominance of this segment in the market.

Clinical segment is anticipated to grow at the fastest CAGR during the forecast period. The segment growth is driven by the increasing number of drug candidates entering early- and late-stage clinical trials, which require specialized small-batch manufacturing and development support from CDMOs. Moreover, rising R&D investments by pharmaceutical and biotech companies, along with growing collaborations with U.S.-based CDMOs for process optimization and regulatory guidance are also some of the factors contributing to the market growth.

Key U.S. Active Pharmaceutical Ingredients CDMO Company Insights

The major players operating across the market are focused on adopting inorganic strategic initiatives such as mergers, partnerships, acquisitions, etc. Moreover, companies focus on technological innovations to augment their market position. For instance, in August 2025, Cambrex announced to expand its active pharmaceutical ingredient (API) manufacturing capabilities in Massachusetts, U.S. The expansion aims to support the development and manufacturing of peptide therapies.

Recent Developments

• In August 2025, Samsun Biologics announced to expand its biomanufacturing capacity to 784,000 liters via Plant 5, with plans for Plant 6. This expansion supports the company's growth in the contract manufacturing market and underscores its commitment to meeting the increasing demand for biologics production.

• In October 2024, Thermo Fisher Scientific Inc. announced to launch the Accelerator Drug Development platform, a 360° Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) solution. This expansion aims to streamline the complex drug discovery and development further enhancing Thermo Fisher's capabilities in the U.S. API market.

U.S. Active Pharmaceutical Ingredient CDMO Market Report Scope

U.S. Active Pharmaceutical Ingredient CDMO Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. active pharmaceutical ingredient CDMO market report based on product, synthesis, drug, application, and workflow.

• Product Outlook (Revenue, USD Million, 2021 - 2033)

  • Traditional Active Pharmaceutical Ingredient (Traditional API)

  • Highly Potent Active Pharmaceutical Ingredient (HP-API)

  • Biologics

• Synthesis Outlook (Revenue, USD Million, 2021 - 2033)

  • Synthetic

  • Biotech

• Drug Outlook (Revenue, USD Million, 2021 - 2033)

  • Innovative

  • Generics

• Workflow Outlook (Revenue, USD Million, 2021 - 2033)

  • Clinical

  • Commercial

• Application Outlook (Revenue, USD Million, 2021 - 2033)

  • Oncology

  • Hormonal

  • Glaucoma

  • Cardiovascular disease

  • Diabetes

  • Others